Siop process for quality assurance

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hi this is rena joran from southeast i'm going to walk you through what we call a qa program quality assurance program let me show you so let's start with topic one what actually do you want to receive what kind of products do you want to receive so specify your requirements in a specific manner and we can help you with that obviously you as a client give us basic product information we can look through it and tell you some comments asking questions then also you ask some you you send some samples to us um you need to clarify actually where you will sell these samples okay if you already you're already aware of some of the compliance requirements um safety related failures and non-safety related failures very important to brainstorm about that you need to do the same also with your packaging what exactly do you need and you already have a sample okay once we have all of that uh it's already a good start we can understand what you are trying to buy if you have access to a bunch of photos of defective products maybe there were some inspections before in the same product on a very similar product we can create a defect library very very useful to guide inspectors at the factory also inspectors working for you and then with all of this information we can then put together a first draft of the checklist okay will be used by inspectors you look through it you give us some comments and we finalize it it's very good if we can get some examples of imperfect samples some of them just at the limit of what you might accept or refuse okay and based on that will help you set some boundaries samples you confirm them okay and this is um best case right for example if a color is very important but it's very hard to to make it clear what kind of tolerance you can accept for example this is something that that is needed for some kinds of products it's not actually needed anyway with all of this information whatever was realistically possible um we can actually explain the quality standard to the people at the factory right and write write some notes about their feedback and tell you about that very important part of this we keep track of the engineering hours project management hours and some other for example fixed fees and then it increments the numbers here and you can have an idea about the total budget okay topic number two is about understanding your risks when it comes to compliance and safety when it comes to product quality when it comes to product reliability right and based on a good understanding of your risks you can actually think of what monitoring is needed what testing is needed what um what needs to be improved and so on okay so what we can do is look through the compliance requirements uh get quotations about the tests that are needed and maybe the certifications when it comes to um the documents from your manufacturer maybe they have some documents about how they will check their components and what they specified and same thing about their manufacturing maybe they have a quality insurance plan we can look at all of this and comment on that and push them to make it better right then on the side we can go inside and do a technical and quality audit right on there there are there's quality systems and looking at their processes um we can also look for example if they say well we have a very strong system we are certified to this and that standard and yes we do use uh statistical process control and things like that we can actually look at that and sometimes it turns out that it's really not effective when it comes to quality and reliability because it's tightly linked doing a design review only from the point of view of quality and reliability right can can actually detect some design weaknesses and also we can look at the manufacturer's plan for the pilot brands and all the verifications and validations that they have done or not in their factory right when developing a new product then a testing plan for reliability getting quotations um and having an idea about when and how the product is likely to fail after shipment after it's in the hands of users all right this is obviously more important for let's say electro mechanical products in general so we have all this information we can list the major sources of risk and think of how this can be managed we can review new document submissions usually when we review we do enough site review and also an on-site review they will have a little bit of homework to improve on certain points so we can review it and we can also conduct failure analysis and some samples that were found none non-functional for example that failed or maybe had a catastrophic failure okay we can we can help in many cases look at them and try to understand okay topic number three is the monitoring okay during production detect the problems detecting issues as early as possible right so uh obviously we work with you to look at what kind of inspections you want that's another sheet just to make sure that you really work as you need then confirm and track the person planning maybe they send us photos of the first finished products and we can look at it in an off-site manner right much cheaper than going on site and spending the whole day there or we can check the first finished pieces from production it's called the first article inspection fai okay that is on-site right uh then the same thing during production inspection on-site or off-site in most cases this is done on site some compliance compliance testing especially if we go on site and we can pick some samples then we can send them to the lab finance inspection in some cases it's good also to do a packing and loading supervision in this case if you see a x here it means it's considered not needed and um contingency plan also in case something fails all right making sure that the factory um will have some clear guideline in what to do and obviously that they will show the cost of additional inspections topic number four is more for the long term if you think you will keep working with that same supplier right so typically we need to know the past issues if there's one particularly costly issue do a full hd analysis of it to not just analysis but problem solving approach to make sure that it doesn't come back in the future right and then simple things such as you know draw a flowchart of the processes uh do a knowledge of these processes do a risk analysis you know fmea is basically a very structured risk analysis to have an idea about the major risks then work together with the manufacturers engineers put in place a control plan on their processes all right this we cannot do it alone they really have to work with us otherwise they will never really follow it um if it doesn't come from them then help them manif uh also document the work instructions which comes you know which has to be tightly aligned with the control plan um and same thing also the qc instructions okay for the qc staff same thing comes from the control plan if you have a good idea about this the control plan is usually better if a good risk analysis was done before okay and then we know what risks have to be controlled and put the controls in place okay if you want to digitize the qc process we can help with that we can have the training some inspectors at the factory set up a few kpis and track the performance of the manufacturer and then keep it to the list for improvements and this to-do list also is fed with the issues that we found in the inspections here right all together in one um one spreadsheet so it's much easier to follow up all right i hope i give you a good overview of what is possible and the way we work with some of our clients let us know if you want to talk about this thank you you